NCT04489420终止1 期
A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults With Recurrent Glioblastoma Multiforme (GBM)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants who experienced a Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.
- •≥ 18 years of age
- •Have measurable disease of at least one solitary lesion with a dimension between 1 cm and 5 cm according to RANO
- •Karnofsky performance status (KPS) ≥ 60
- •Adequate organ function defined by laboratory values as follows: Creatinine < 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥40 mL/min, Bilirubin < 20% above the upper limit of normal, AST and ALT ≤ 2.5 the upper limit of normal.
- •Absolute Neutrophil count baseline (ANC) ≥1500 cells/uL, Hemoglobin baseline ≥ 9.0 g/dL and Platelets baseline ≥ 100,000 cells/uL prior to the start of study treatment.
- •Female of childbearing potential (FCBP) must not be pregnant and agree to not becoming pregnant for at least 42 days following the start of the treatment.
- •Patients with HIV/AIDs are eligible if they have not had an opportunistic infection within the past 12 months
- •Patients with chronic HBV infection or patients with current or a history of HCV infection are allowed if:
- •have an HBV viral load below the limit of quantification and be on viral suppressive therapy
- •have current HCV infection, they should be on concurrent HCV treatment and the HCV viral load must be below the limit of quantification
- •have a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
排除标准
- •Had prior radiation therapy within 12 weeks of screening MRI unless there is unequivocal histological confirmation of tumor progression
- •Subjects on growth factors therapy with less than 4 weeks washout period (for short-acting growth factors, such as G-CSF, GM-CSF 5-day wash-out for longer-acting factors (such as Neulasta) 10 days
- •Radiotherapy, chemotherapy, or other investigational agents within 4 weeks
- •Prior cellular or gene therapy at any time
- •Clinical or laboratory signs for immunodeficiency or under immunosuppressive medication or steroids greater than15 mg prednisone or equivalent per day
- •History of malignancy, other than GBM, unless the subject has been free of disease for > 3 years from the date of signing the ICF. Exceptions include the following noninvasive malignancies: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •Active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy
结局指标
主要结局
Number of Participants who experienced a Dose-Limiting Toxicity (DLT)
时间窗: Day 42
Defined as the maximum dose safely administered intravenously or Intratumoral for the treatment of patients with GBM.
Adverse Events (AEs)
时间窗: 1 year
Defined as the number and Severity of Adverse Events
次要结局
- Overall Response Rate(1 year)
- Progression-free survival(1year)
- Time to porgression(1year)
- Duration of Response Rate(1year)
- Overall Survival(1year)
研究者
研究点 (2)
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